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Health Regulations: Single Exit Prices for Medicines; Pesticide Residues in Fruit and Vegetables; Foodstuff Labelling

Department of Health

Amendments have been published to health regulations affecting single exit prices for medicines, pesticide residues in fruit and vegetables, and the labelling and advertising of foodstuffs.

They can be found in notices R47, R48, R45 and R46 of Government Gazettes 34959, 34957 and 34958 respectively, all dated 19 January 2012.

According to notice R47, adjustments to the single exit price of medicines and scheduled substances should not exceed 2.14% of those currently applicable and must be received before 30 March 2012.

Further, manufacturers and importers of medicines and scheduled substances may only implement an adjustment to the single exit price of a product 30 working days after communicating the information required in terms of regulation 21 of Medicines and Related Substances Act 101 of 1965.

Notice R48 formally requests manufacturers and importers of medicines and scheduled substances to submit the necessary information set out in regulation 21.

According to the notice, such information should include the applicant’s entire portfolio of products, regardless of whether or not an adjustment is required.

Amendments to regulations relating to the labelling and advertising of foodstuffs are immediately effective.

Inter alia, they apply to:

•    flour confectionary;
•    glycaemic carbohydrate;
•    speciality breads;
•    “novel fibres”; and
•    preservatives.

Amendments to regulations made in terms of Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 include:

•    definitions for citrus, pome and stone fruits; and
•    maximum limits for pesticide residues in fruit, vegetables, hops and tobacco.

Sabinet Cape Town Office

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